Phase 2
N=64
Motexafin Gadolinium and Radiation Therapy in Treating Young Patients With Pontine Glioma
Untreated Childhood Brain Stem Glioma
Bottom Line
View on ClinicalTrials.gov: NCT00387790 ↗Enrolled (actual)
64
Serious AEs
17.7%
Results posted
Feb 2014
Primary outcome: Primary: One Year Event-free Survival (EFS) — 20 percent probability
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- motexafin gadolinium (Drug); 3-dimensional conformal radiation therapy (Radiation)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY One Year Event-free Survival (EFS) |
20 | — |
| SECONDARY Overall Survival (OS) |
53 | — |
| SECONDARY The Number of Patients Who Experience at Least One Grade 3 or Higher CTC Version 4 Toxicity. |
31 | — |
Summary
This phase II trial is studying how well giving motexafin gadolinium together with radiation therapy works in treating young patients with pontine glioma. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as motexafin gadolinium, may make tumor cells more sensitive to radiation therapy. Giving motexafin gadolinium together with radiation therapy may kill more tumor cells.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of intrinsic pontine glioma (brain stem glioma)
- Clinical and radiographic (MRI) evidence of tumors that diffusely involve the brain stem (i.e., tumors that intrinsically [> 50% intra-axial] involve the pons or pons and medulla, pons and midbrain, or entire brain stem) allowed
- Tumor may contiguously involve the thalamus or upper cervical cord
- No more than 1 lesion/mass present at diagnosis
- Karnofsky performance status (PS) 60-100% (age > 16 years) OR Lansky PS 60-100% (age ≤ 16 years)
- Life expectancy ≥ 8 weeks
- Absolute neutrophil count ≥ 1,000/mm³
- Platelet count ≥ 100,000/mm³ (transfusion independent)
- Hemoglobin ≥ 10 g/dL (RBC transfusions allowed)
- Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR creatinine normal for age/gender (0.4-1.7 mg/dL)
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- ALT < 1.5 times ULN
- No known glucose-6-phosphate dehydrogenase (G6PD) deficiency
- If family history suggestive of congenital hemolytic anemia, patient must be screened for G6PD with G6PD activity test prior to study entry
- No biliary obstruction
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior definitive therapy for this specific tumor
- No prior cranial radiotherapy
- Concurrent steroids and anticonvulsants allowed
- No concurrent proton therapy
- No concurrent intensity-modulated radiotherapy
- No concurrent anticancer chemotherapy
- No concurrent immunomodulating agents
Data sourced from ClinicalTrials.gov (NCT00387790). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.